Drug factory · FDA FEI 3012663162
Fordoz Pharma Corporation
69 Princeton Hightstown Rd, East Windsor, NJ, United States
Serious problems, FDA action at FDA's last inspection, Nov 12, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
1 drug inspection on record since 2025: 0 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Doxorubicin | Makes it, tests it and packages it | BluePoint Laboratories. | 68001-629 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 12, 2025 | Serious problems, FDA action | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 12, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy.
Registered with FDA for: analysis; label; manufacture; pack.